Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Pfizer’s trastuzumab becomes US biosimilar number 18

The US Food and Drug Administration (FDA) has approved Trazimera, Pfizer’s version of Roche cancer drug Herceptin (trastuzumab).

Trazimera has been approved as a biosimilar version of Herceptin to treat human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

It is the fourth version of the Roche bestselling monoclonal antibody (MAb) to receive the regulatory thumbs up in the US. Mylan’s Ogiviri received approval in December 2017 and in the past three months Celltrion and Samsung Bioepis/Merck & Co. have seen regulatory success with their respective trastuzumab programs.

Image: iStock/chatsimo

So far none of these trastuzumab biosimilars have launched in the US and Roche’s monopoly remains unthreatened. In 2018, the MAb pulled in CHF 2.9 billion ($2.9 billion) in US sales for the Swiss biopharma firm.

“Pfizer is working to make Trazimera available to patients as soon as possible,” Pfizer spokesperson Jessica Smith told BioProcess Insider. When asked, Smith was unable to offer further details regarding launch, specific pricing or commercialization strategies.

“However, by introducing biosimilars like Trazimera to the US market, Pfizer hopes that patients and their physicians will have improved access to a high-quality, potentially lower-cost alternative trastuzumab treatment option within its approved indications.”

US biosimilars by numbers

Trazimera is Pfizer’s fifth biosimilar to be approved by the FDA and its first biosimilar MAb.

It is the eighteenth biosimilar to be granted approval and the fourth trastuzumab biosimilar.

The full list is as follows:

March 2015: Sandoz’s Zarxio (filgrastim-sndz), a version of Amgen’s Neupogen

April 2016: Pfizer’s Inflectra (infliximab-dyyb ), a version of J&J’s Remicade

August 2016: Sandoz’s Erelzi (etanercept-szzs), a version of Amgen’s Enbrel

September 2016: Amgen’s Amjevita (adalimumab-atto), a version of AbbVie’s Humira

April 2017: Samsung Bioepis/Merck’s Renflexis (infliximab-abda), a version of J&J’s Remicade

August 2017: Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm), a version of AbbVie’s Humira

September 2017: Amgen and Allergan’s Mvasi (bevacizumab-awwb), a version of Roche’s Avastin

December 2017: Mylan and Biocon’s Ogivri (trastuzumab-dkst), a version of Roche’s Herceptin

December 2017: Pfizer’s Ixifi (infliximab-qbtx), a version of J&J’s Remicade

May 2018: Pfizer’s Retacrit (epoetin alfa-epbx), a version of Amgen’s Epogen and Procrit

June 2018: Mylan and Biocon’s Fulphila (pegfilgrastim-jmdb), a version of Amgen’s Neulasta

July 2018: Pfizer’s Nivestym (filgrastim-aafi), a biosimilar to Amgen’s Neupogen